Comparison of desogestrel and levonorgestrel releasing intrauterine device in terms of menstrual pattern, side effects and patient satisfaction in postpartum contraception

• Register: ANZCTR
• Last refreshed on: 5 January 2021
• Main ID: ACTRN12614000889651
• Date of registration: 21/08/2014
• Prospective Registration: Yes
• Primary sponsor: Mine Kiseli
• Public title: Comparison of desogestrel and levonorgestrel releasing intrauterine device in terms of menstrual pattern, side effects and patient satisfaction in postpartum contraception
• Scientific title: Comparison of desogestrel and levonorgestrel releasing intrauterine device in terms of menstrual pattern, side effects and patient satisfaction in postpartum contraception
• Date of first enrolment: 01/09/2014
• Target sample size: 112
• Recruitment status: Withdrawn
• URL: https://anzctr.org.au/ACTRN12614000889651.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Turkey

Contacts

• Name: Dr Mine Kiseli

• Name: Dr Mine Kiseli

Key inclusion & exclusion criteria

Inclusion criteria: Patients who were prescribed oral desogestrel or who were applied levonorgestrel releasing intrauterine device for postpartum contraception
Six weeks passed after vaginal birth and 8 weeks passed after cesarean section
Patients giving consent for the participation to the study
Exclusion criteria: History of acute artery or vein thrombosis
6 months passed after the delivery
Women with acute or chronic liver disease, diabetes, hypertension or renal disease
Women having postpartum depressive symptoms
Patients who won't give consent for the participation

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Contraception

Postpartum contraception;
Postpartum contraception

Intervention(s)

Arm 1: Desogestrel 75 mcg/day orally 28 days, continously, observation for 12 months.
Arm 2: Levonorgestrel releasing intrauterine device applied by the physician which releases 20mcg levonorgestrel/day into the endometrial cavity, observation for 12 months.

Primary Outcome(s)

Primary outcome is the menstrual pattern of the patient
Patients willing to participate into the study will be given a calender and they will be asked to mark the days with spotting, days with bleeding or days with heavy bleeding each month. [Third month, sixth month and 1st year after the method was started]

Secondary Outcome(s)

Side effects of desogestrel or levonorgestrel releasing intrauterine device.
Possible side effects will be asked to the patiens and side effect notification forms will be filled up by the physician.
Irregular bleeding
Spotting
Headache
Nausea
Breast tenderness
Depressive symptoms
Acne
Amenorrhea
Weight gain
Mood changes
Vaginal discharge
Pelvic infection
Others[Third month, sixth month and 1st year after the method was started]

Patient satisfaction
Patients will be asked if they are satisfied with the method and if they wish to continue. If they are not pleased the reason will be asked and noted. Special query forms are prepared for the visits. [Third month, sixth month and 1st year after the method was started]

Secondary ID(s)

None

Source(s) of Monetary Support

No funding exist

Ethics review

Status: Approved
Approval date: 13/01/2014
Contact:

Ankara University Faculty of Medicine Ethics Committee